The potential for pathogen contamination of blood products remains an important medical issue throughout the world. Although improved testing methods for the presence of certain key pathogenic viruses have markedly reduced the incidence of diseases associated with administration of blood products, concerns regarding the safety of the blood supply continue. Furthermore, other viral, bacterial, and unknown agents that are not routinely tested for, remain a potential threat to administration of blood products. In addition, testing of the blood supply cannot insure the safety of blood and blood products against future unknown pathogens that may enter the donor population and potentially result in disease transmission before sensitive tests can be implemented. Although less affected by such concerns, protein therapeutics produced by recombinant or transgenic means are also subject to contamination by pathogenic agents.
An alternative approach to eliminate transmission of viral or other potential diseases through blood products is to develop a means to reduce active pathogens in blood products. Methodologies currently employed to reduce the risk of pathogen contamination of blood products include various filtration and chromatographic techniques. These process steps may be specifically dedicated to pathogen clearance or part of an overall blood product fractionation scheme. However, the preparation and maintenance of equipment used in the fractionation of blood products necessitates sanitization or decontamination, which can be difficult. For example, chromatographic fractionation of pathogen-tainted plasma intermediates may result in residual contamination of chromatographic media itself. This presents a source of potential pathogen transmission to the product stream if the media is regenerated for further use. Accordingly, a need exists for reliable sanitization of reusable chromatographic media used in the preparation of blood products.